Project: Improving HIV prevention and sexual and reproductive health care in high risk women in Rwanda using lessons learnt from previous Rinda Ubuzima projects

Acronym WISH (Reference Number: EDCTP-CSA-2014-273)
Duration 01/01/2016 - 31/12/2017
Project Topic Rinda Ubuzima (RU) in Kigali, Rwanda, is a non-governmental organisation (NGO) specialised in HIV prevention and sexual and reproductive health (SRH) research in women. RU has operated a research clinic and laboratory in Kigali since 2004, and has successfully implemented three EDCTP1-funded projects. The purpose of this project is to use the capacity that RU has built to: 1) formalise its role as an HIV prevention/SRH research and training centre in Rwanda; 2) demonstrate to and with stakeholders (including Ministry of Health (MoH) policymakers, University of Rwanda (UR) College of Medicine and Health Sciences (CMHS) teaching staff, and representatives of other HIV/SRH care organisations in Rwanda) that it is feasible and affordable to improve SRH services in high risk women using results from previous RU studies; and 3) engage stakeholders in discussions about potential adaptations of the Rwanda sexually transmitted infection (STI) treatment guidelines, potential opportunities for better integration of vertical HIV and SRH programs, and preparations for roll-out of novel vaginal microbides and multipurpose prevention technologies for HIV and pregnancy prevention as soon as efficacious products become available. The first aim will be achieved by signing memorandums of understanding (MOUs) with MoH and UR-CMHS about RU’s role, offering internships to UR-CMHS students at RU, and assisting potential PhD candidates with HIV/SRH-related fellowship applications. Furthermore, RU will conduct a year-long demonstration project, offering improved HIV/SRH services to high risk women at RU premises. The improvements will consist of creating a ‘safe space’ for high risk women, offering HIV testing to everyone, replacing syndromic STI management with point-of care (POC) tests and risk-scoring, ensuring integration and/or linkage with other HIV/SRH services, offering same-day services, and allowing for community input into the services. Two workshops with stakeholders will be held: one prior to the start of the demonstration project to agree on the services to be offered as well as the monitoring and evaluation (M&E) indicators to be measured, and one after completion to discuss potential revisions of the Rwandan STI treatment guidelines and to plan for roll-out of improved services to other clinics in Kigali servicing high risk populations. The workshops, as well as in-depth interviews with key stakeholders, will also be used to address integration of services and future roll-out of novel HIV prevention technologies (aim 3). Increased HIV testing and improved control of STIs and vaginal infections will reduce HIV transmission and is therefore of direct relevance to EDCTP2.
Project Results
(after finalisation)
The high burden of sexually transmitted infections (STIs) and other urogenital infections worldwide has long been recognised by the World Health Organisation (WHO). In an effort to control such infections in resource-poor settings with no or limited laboratory infrastructure, the so-called ‘syndromic management guidelines’ were launched in 1978. These guidelines categorise infections by the symptoms they cause (such as ‘vaginal discharge syndrome’), and call for treatment of all pathogens that might cause that syndrome. The obvious advantage of this approach is that no laboratory testing is needed, but the obvious disadvantage is that all asymptomatic infections are missed. The main aim of the WISH project (https://www.liverpool.ac.uk/infection-and-global-health/research/diagnostics/WISH; https://clinicaltrials.gov/ct2/show/NCT03045809) was to improve case-finding and management of urogenital infections in Rwandan women by introducing point-of-care (POC) diagnostic testing. Rwandan women at risk of STIs (defined as more than one sex partner and/or treated for STIs in the last year) were offered POC testing at the Rinda Ubuzima research clinic in Kigali for bacterial vaginosis (BV; pH≥5.0 on Ecocare vaginal pH swab, Merete Medical, Luckenwalde, Germany), Trichomonas vaginalis (TV OSOM, Sekisui Diagnostics, San Diego, CA, USA), HIV (Rwanda national algorithm) and pregnancy (locally available hCG test), regardless of symptom-reporting. Women who had a positive risk score (at least one of the following: currently pregnant, at high sexual risk, or showing clinical signs of offensive vaginal discharge and/or pelvic inflammatory disease, or genital ulcer disease, respectively) were also offered a Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) POCT (GeneXpert, Cepheid, Sunnyvale, CA, USA) and/or syphilis POCT (Alere Determine, Alere International, Galway, Ireland); the risk-scoring was done in an effort to reduce costs. Vulvovaginal candidiasis (VVC) was managed presumptively. We aimed to complete all diagnostic procedures per woman within one half day, but women could opt to leave and return later. Gold standard (GS) diagnostic testing was done by PCR on stored samples from all women (see footnotes Table 1) soon after their clinic visit; women were recalled for treatment if an infection for which they had not been treated previously was identified. HIV, syphilis, and pregnancy POCTs are known to have good performances and were offered without further evaluation. Syndromic diagnoses were reconstructed using participant-reported symptoms prior to diagnostic testing. Diagnoses by the Rwandan syndromic algorithms, WHO syndromic algorithms and WISH algorithms were each compared to GS-diagnoses. Between July 2016 and March 2017, 705 women were enrolled, including 59 pregnant women. Procedures were completed within one half day for almost all women and both staff and client satisfaction were high. Almost half (45.4%) of 690 women with valid GS test results had at least one infection: 8.5% CT, 7.1% NG, 16.1% TV, 18.1% BV, 8.6% VVC, and 3.0% syphilis. All Rwandan and WHO syndromic algorithms had poor performance (data not shown). The CT/NG and TV POCTs had good performance . Risk-scoring prior to testing resulted in 25.0% missed CT/NG cases but reduced the number of tests by 43.8%. BV by vaginal pH and presumptive VVC diagnoses had poor overall performance . However, the negative predictive value of vaginal pH≥5.5 for BV was 92%, and pregnant women were much more likely than non-pregnant women to have GS-VVC (and less likely to have GS-BV). We therefore devised an alternative ‘optimal’ algorithm in which only women with vaginal pH≥5.5 would undergo GS-BV testing and only pregnant women would undergo GS-VVC testing. This resulted in good performance for BV (sensitivity 73.6% and specificity 100%), but low sensitivity (18.6%; specificity 100%) for VVC because all cases in nonpregnant women would be missed by definition . If non-pregnant women with persistent or recurrent VVC symptoms would also undergo GS-VVC testing, sensitivity would likely increase, but we cannot test this hypothesis with WISH data. The WISH study also showed that speculum and bimanual examinations did not significantly aide in the diagnosis of infections (other than pelvic inflammatory disease and genital ulcers/warts) and could be reduced, and that partner notification should be improved. We concluded that the prevalence of urogenital infections is high in this study population, that participant-reported symptoms and physician-observed signs do not reliably predict the presence of urogenital infections, and that POC testing was feasible and highly acceptable in the Kigali setting. However, some POCTs are prohibitively expensive for resource-poor settings (particularly the GeneXpert CT/NG test) and better POCTs are needed for BV and VVC (preferably one combined POCT for BV and VVC, and potentially also TV). These results were discussed with stakeholders in Rwanda in December 2017. Everyone agreed that syndromic management for urogenital infections in women is not adequate. Everyone also agreed that the introduction of POC testing for the most common urogenital infections is required, and that this is feasible in the Rwandan context in terms of infrastructure and staff ability to conduct the tests appropriately, but concerns were expressed about the associated costs. It was agreed that POC testing is not only associated with costs but also with savings (e.g. reduction of unnecessary antibiotic or antifungal treatments) and that some of the complications (especially preterm birth) are worthwhile preventing even if this does require government investments. The Rwanda Ministry of Health requested cost-effectiveness studies and guidance from WHO. The WISH results will be shared with the WHO staff responsible for STI control policies, and will be presented at international conferences and in international peer-reviewed publications in 2018.
Website visit project website
Network EDCTP2
Call Maximising the impact of EDCTP research: translation of research results into policy and practice

Project partner

Number Name Role Country
1 University of Liverpool Coordinator United Kingdom
2 Rinda Ubuzima Partner Rwanda
3 Prins Leopold Instituut voor Tropische Geneeskunde Partner Belgium